Global Clinical Trial Leader

Job Title: Global Clinical Trial Leader (CTL)

Location: South San Francisco, CA (Hybrid – 3 Days Onsite)

Duration: 12 Months Contract

Schedule:

• Hybrid 3 days onsite/ 2 days WFH (three days onsite, two days remote - Tuesdays and Thursdays are anchor days)
• Working Days: Monday through Friday
• Working Hours: Standard eight (8 AM to 4 PM or 9 AM to 5 PM PT)

Key Responsibilities:

• Lead and support global Phase I/II clinical trials from study start-up through close-out.

• Provide operational leadership to cross-functional Protocol Execution Teams (PETs).

• Manage CROs, vendors, study timelines, budgets, and risk mitigation activities.

• Oversee trial documentation including TMF, CTMS, monitoring plans, and drug supply forecasting.

• Support site selection, country feasibility, protocol development, and investigator meetings.

• Collaborate with internal and external stakeholders to ensure successful trial execution.

• Contribute to process improvement initiatives and mentor junior team members.

Required Qualifications:

• Bachelor's degree in Life Sciences, Healthcare, or related field.

• 8+ years of clinical study management experience.

• Strong experience managing global Phase I/II clinical trials.

• Proven CRO/vendor management and oversight experience.

• Knowledge of GCP, ICH guidelines, and the drug development process.

• Experience with TMF, CTMS, study start-up, conduct, and close-out activities.

• Excellent communication, stakeholder management, and problem-solving skills.

Preferred Skills:

• Global Clinical Trial Management

• Clinical Operations

• Risk Management & Mitigation

• Budget Management

• Cross-Functional Leadership

• Protocol Feasibility & Site Selection

• Investigator Meeting Management

• Process Improvement & Change Management